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The acupuncture needle is a device intended to pierce the skin in the practice of acupuncture. The device consists of a solid, stainless steel needle. The device may have attached to the needle to facilitate the deliyery of acupuncture treatment.

The device consists of a solid, stainless steel needle. The device may have attached to the needle to facilitate the deliyery of acupuncture treatment.

This document is a 510(k) clearance letter from the FDA for several brands of acupuncture needles. It does not contain information about the acceptance criteria or a study proving that an AI device meets such criteria. Therefore, I cannot provide the requested information based on the given text.

The document discusses:

• Device Name: Eacu, Zagu, Jocu, Eaku, Balance, Tempo, Acuzone, Smart, Prime, Acuking, Myotech Dry, Red Coral Premium, Red Coral J-type, Red Coral Natural Acupuncture Needles
• Regulation Number: 21 CFR 880.5580
• Regulation Name: Acupuncture Needle
• Regulatory Class: II
• Product Code: MQX
• Indications for Use: The acupuncture needle is a device intended to pierce the skin in the practice of acupuncture. The device consists of a solid, stainless steel needle. The device may have attached to the needle to facilitate the delivery of acupuncture treatment.

There is no mention of any AI device, performance criteria, study data, sample sizes, expert ground truth, or comparative effectiveness studies.

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